Method of selling procedure specific allografts and associated instrumentation

ABSTRACT

A method for selling a product and all phases of service and support to a customer for optimal use of the product includes customizing a product for a surgical allograft procedure to be performed and providing the customized product and services as an integrated turnkey package to a medical provider. The products include bone and soft tissue allografts for all types of orthopedic reconstructive procedures and a loan of the associated instrumentation. The service portion of the package includes training support on use of the instruments, training of operating room personnel, technical and customer support both before the performance of the procedure and on-site support. After completion of the surgical procedure, the service provider arranges for the return of the loaned instrumentation.

This application claims the benefit of U.S. Provisional Application Ser.No. 60/241,764, filed Oct. 20, 2000.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to a business method of selling a surgicalproduct and necessary instrumentation for using the product togetherwith a service package including training for using the product andassociated instruments, customer service and technical support.

2. Brief Description of the Related Art

In preparing to perform a surgical procedure requiring a bone or softtissue allograft, it was heretofore necessary for the surgeon, hospital,or medical center performing the procedure to make arrangements with atissue bank for the delivery of the allograft within the appropriatetime window prior to the surgery. If the surgeon or medical facilitydoes not already own the necessary instrumentation to be used to performthe procedure, then separate arrangements must also be made to purchase,lease or borrow the appropriate instruments through a provider oranother medical facility. Additionally, the surgeon performing theprocedure may need training if he or she is unfamiliar with theprocedure or needs a “refresher” course, thus requiring additionalarrangements to be made with yet another entity who can provide thetraining. Thus, the administrative preparation for the surgicalprocedure can become quite complex and time consuming for the medicalprovider.

SUMMARY OF THE INVENTION

To address the disadvantages encountered in the prior art, it is anobject of the present invention to streamline the pre-operative processfor the medical provider to thereby enable the medical provider to focuson providing medical care to its patients.

It is also an object of the present invention to provide a comprehensiveturnkey service to a medical provider as support for the performing of asurgical allograft procedure.

It is a further object of the present invention to provide a businessmethod of selling a surgical product along with a loan of the necessaryinstrumentation for using the product, together with a service packageincluding training on using the product and associated instruments,customer service and technical support.

It is a still further object of the present invention to maintain anongoing business relationship with a source provider of the surgicalproduct as part of the business method to facilitate providing theturnkey service to the medical provider.

The present invention is a method for selling a product and all phasesof service and support to a customer for optimal use of the product.Moreover, the product itself is specially designed according to theconditions and needs of the procedure to be performed.

In particular, the products include bone and soft tissue allografts forall types of orthopedic reconstructive procedures and a loan of theassociated instrumentation. The service portion of the package includestraining support on use of the instruments, training of operating roompersonnel, technical in-service and customer support.

When the surgeon determines that allograft surgery is necessary, uponcompiling the necessary medical data, the surgeon or hospital places theorder for the allograft through the service provider, who then makes theappropriate arrangements to coordinate the delivery of the allograftfrom a tissue bank with the assembly and delivery of a customized set ofinstrumentation for the specific procedure. The service provider alsoarranges for any training which may be necessary for the surgeon,provides for the presence of a service representative in the operatingroom to assist the surgeon during the procedure, and arranges for thereturn of the loaned instrumentation after the procedure.

Other features and advantages of the present invention will becomeapparent from the following description of the invention which refers tothe accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWING

FIG. 1 is a flowchart illustrating the method in accordance with thepresent invention.

DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION

The present invention is a business method of providing an integratedproduct and service package for orthopedic surgery practitioners, and isillustrated in the flow chart shown in FIG. 1. Specifically, theinventive method serves as a single source provider of bone and softtissue allografts for reconstructive surgical procedures, associatedinstrumentation and peripheral materials to perform the specifiedsurgical procedure, and all levels of training, service and support inthe use of the products.

Upon determination between an orthopedic surgeon and a patient that areconstructive procedure is to be performed (step S1), the practitionerdetermines the specifications for the grafts needed for the procedure,and then collects relevant records and information useful for obtaininga customized allograft for the procedure (step S2). Such data to becollected may include the patient's blood type, the identification ofany antibiotic or other allergies suffered by the patient, thedimensions of the grafts needed, X-rays and/or other pre-operativedocumentation.

The surgeon or the medical facility then places an order with theservice provider which practices the business method of the presentinvention, and provides the obtained medical data to the serviceprovider (step S3). The medical provider can order the allografttogether with a loan of the associated instrumentation for performingthe allograft procedure, or, if the medical provider already owns theappropriate instrumentation, the allograft only.

As part of the overhead structure of the business method arrangement,the service provider maintains an ongoing relationship with one or moretissue banks, in which the service provider provides instrumentation andtraining to the tissue bank personnel as needed for harvesting theallografts in accordance with the processing techniques andspecifications for the procedures indicated by the customer. Suchrelationship is mutually beneficial to both the service provider and thetissue bank since the tissue bank personnel receives updated equipmentand ongoing opportunities for training in the use of the instrumentationand harvesting techniques, while the service provider is assured of areliable source of size specific allografts prepared specifically forthe surgical procedures to be performed and the instrumentation to beused by the customers.

In accordance with the business arrangement between the tissue bank(s)and the service provider, when an order is received from a medicalprovider customer, the service provider contacts the tissue bank toarrange for a graft to be harvested in accordance with thespecifications and indications provided by the medical provider, and toschedule the delivery of the allograft within a designated time frameprior to the scheduled surgery (step S4).

The allografts are harvested at the tissue bank from donors understandard operating room sterile techniques and are subjected toextensive tests and studies to guard against the possibility oftransmission of HIV, hepatitis, and other infections and to avoidproblems with recipient immune sensitization and antibioticsensitivities.

The allografts are preferably non-irradiated and can be preserved by anymethod, including fresh preserved, fresh freezing, cryopreservation,freeze-drying, and decellurization. Furthermore, the allografts arecustomized to the specifications and conditions of the patient and theprocedure. For example, the dimensions of the graft can be specificallyobtained to accommodate requested dimensions (diameter, length, widthand/or thickness of the grafts), or if a patient is known to besensitive to certain antibiotics normally used in the processing of theallografts, the allografts can be prepared without the use ofantibiotics.

Examples of the types of grafts which may be supplied in accordance withthe present method include size specific osteochondral cores; cancelloustunnel plugs; femoral and tibial meniscus allografts (frozen andcryopreserverd) including femoral menisci with bone blocks and tibialplateau with meniscus; proximal tibial and distal femoral bone wedges;cortical cervical rings; fresh osteochondral allografts such as femoralhemi-condyles, whole distal femurs, trochleas, talus, and patellas; andanterior cruciate and posterior cruciate ligament reconstructionallografts (frozen and cryopreserved) including Achilles tendons withbone blocks, quadriceps tendons with bone blocks, hamstrings(semi-tendinosus, gracilis), anterior and posterior tibialis tendons,bone-tendon-bone tendons, and hand and foot flexor and extensor tendons.

For each order in which a loan of the corresponding instrumentation forthe selected allograft has been requested, a customized instrumentationkit is assembled to include the appropriate precision instruments andfixation elements, such as fixation plates, interference screws, etc.,taking into account the type and size of the requested allograft, foroptimally implanting the graft (step S5). Preferably, the instrumentsloaned to the surgeon or medical facility for the operation are owned bythe service provider. Alternatively, the service provider may arrangefor the instruments to be sent to the surgeon or medical facility fromanother provider.

The service provider confirms the delivery date of the grafts and workswith the patient's medical team to establish a system of training, ifnecessary, to take place either at the surgeon's facilities and/or anoutside training facility, which may be operated by the service provideror a third party (step S6).

In accordance with the schedule determined between the service providerand the surgeon, the graft specific instrumentation, fixation aids, andassociated materials are delivered to the operating location forin-service with the operating room staff and for sterilization (if notalready provided in a sterilized state) (step S8). Meanwhile, at thetissue bank, the allograft is harvested according to the specificationsindicated by the medical provider (step S7), and then packaged andshipped to the surgeon or hospital in a cooled packaging, if necessary(step S9). The delivery of the graft is coordinated to be delivered tothe designated medical facility with a simultaneous or temporallyproximal delivery of the graft specific instrumentation and relatedmaterials needed to perform the implantation. Preferably, the procedurespecific allograft is shipped from the tissue bank by overnight deliveryto the operating location 1-2 days in advance of the surgery, to arriveno later than the day of the operation.

If the operation is unforeseeably postponed or otherwise does not takeplace withing a day or two of the date the allograft is received fromthe tissue bank, the surgeon should at least keep in mind that freshgrafts such as precut osteochondral cores must be used within 14 days tomaintain live cells in the allograft. With frozen or cryopreservedallografts, however, more flexibility may be afforded for the usabletime frame of the graft, provided the receiving medical provider hasadequate storage facilities to appropriately maintain the viability ofthe graft.

Prior to and during the surgical procedure, the service providerprovides technical and customer support to ensure smooth operation ofthe procedure and to maximize the degree of success achieved by theprocedure (S6, S10). In particular, if desired by the surgeon, theservice provider sends a technical service representative who isknowledgeable about the surgical procedure and the use of theinstrumentation and associated materials to be present with the surgeonat the time of surgery (step S10) to provide technical support andguidance for the surgeon and the operation staff during the operation(step S11).

After the operation is completed, a representative of the providerfacilitates return of the loaned instrumentation and any othernon-disposable materials to the provider (step S12).

As described above, the present invention provides a turnkey system inwhich a service provider loans a medical provider a customizedinstrumentation kit as an integrated package with the allograft for aspecified surgical procedure, along with training and technical supportservices. Since tissue banks generally do not provide theinstrumentation or training needed to implant a graft harvested fromtheir facilities and instrument companies generally do not sellallografts, the system of the present invention streamlines thepre-operative administrative preparation process for the medicalprovider so that the medical provider need only place an order with theservice provider for all the necessary arrangements to prepare for thesurgical procedure.

As a business venture, the turnkey system and method of providing theintegrated product and service package described herein is profitablefor the service provider by charging the medical provider a fee betweenabout 50% to 100% above the cost of obtaining the allograft from thetissue bank. The profit collected by the service provider is based uponthe rental of the instrumentation, the intra-operative support,educational training, and service coordination efforts, and not on thesale of the allograft, as such sale would likely pose ethical concerns.

However, medical facilities often cannot or will not bill for loanerfees for the instrumentation, because most insurance carriers onlyprovide coverage for products and services received for medical care.More specifically, most insurance carriers will not reimburse a medicalprovider or a patient for the rental costs of instrumentation, becausethey are ultimately returned to the instrument provider where neitherthe patient nor the medical provider will derive further future benefitor use from the loaned instrumentation (unless another loaner fee ispaid to the instrument provider). Thus, the fee charged for theintegrated product and service package is billed to the customer as theprice of the graft, while the rental of the instrumentation andassociated materials are included for free as part of the package. Inthis manner, the entire cost of the package (obtaining the allograft atcost through the tissue bank plus the rental fee for theinstrumentation) is built into the cost of the allograft. The tissuebank recovers the cost of providing the allograft from the serviceprovider. Such cost thus represents a portion of the cost of theintegrated package paid by the medical provider (or the insurancecarrier) to the service provider.

Although the present invention has been described in relation toparticular embodiments thereof, many other variations and modificationsand other uses will become apparent to those skilled in the art. It ispreferred, therefore, that the present invention be limited not by thespecific disclosure herein, but only by the appended claims.

1-17. (canceled)
 18. A method of preparing a customized donor allograftfor a predetermined surgical procedure, the method comprising: receivingpredetermined specifications and conditions of a patient to undergo thepredetermined surgical procedure, said predetermined specifications andconditions being received from a medical provider; harvesting and sizingto a specific diameter, length, width and/or thickness, at least one ofa meniscal and an osteochondral donor allograft according to thepredetermined specifications and conditions of the patient, and alsoaccording to the predetermined surgical procedure to be performed on thepatient, thereby creating said customized donor allograft; effectingdelivery of the customized donor allograft to the medical provider, anddelivering surgical instrumentation to the medical provider, saidsurgical instrumentation being selected based on the customized donorallograft and on the predetermined surgical procedure.
 19. The method ofclaim 18, wherein a tissue bank delivers the customized donor allograftdirectly to the medical provider.
 20. The method of claim 18, whereinthe surgical instrumentation includes at least one of a fixation plateand an interference screw.
 21. The method of claim 18, wherein thecustomized donor allograft is prepared without the use of antibiotics.22. The method of claim 18, wherein the customized donor allograft isdelivered to a medical facility at which the predetermined surgicalprocedure is to be performed.
 23. The method of claim 18, furthercomprising training operating personnel in the use of the surgicalinstrumentation to perform the predetermined surgical procedure.
 24. Themethod of claim 18, wherein the surgical instrumentation is loaned tothe medical provider, and wherein the medical provider returns thesurgical instrumentation to the first business entity after thepredetermined surgical procedure is completed.
 25. The method accordingto claim 18, further comprising providing technical support during theprocedure.
 26. The method according to claim 25, wherein the step ofproviding technical support includes providing for the presence oftrained representative knowledgeable in the use of the instruments andthe performance of the surgical procedure at an operation locationduring the procedure.